(68 days)
The Femoral Neck System (FNS) is indicated for femoral neck fractures, including basilar, transcervical, and subcapital fractures, in adults and adolescents (12-21) in which the growth plates have fused or will not be crossed.
The subject Femoral Neck System is comprised of implants designed to treat femoral neck fractures as well as system-specific insertion instruments. The Femoral Neck System is a modular system consisting of four connected implant components forming a fixed-angle gliding fixation device which allows for controlled collapse of the femoral neck. The implants are manufactured from Titanium Alloy and are provided in a range of dimensions. The same construct can be used for the left and right femur.
The provided document is a 510(k) summary for the DePuy Synthes Femoral Neck System, a medical device for femoral neck fractures. It does not contain information about a study with acceptance criteria for device performance in the context of an AI/algorithm-based medical device.
Instead, the document details the regulatory clearance process for a physical medical implant, the Femoral Neck System (FNS). The "performance data" mentioned refers to non-clinical evaluations of the implant's mechanical properties, not an AI algorithm's diagnostic or predictive performance.
Therefore, I cannot extract the requested information as it is not present in the provided text. Specifically:
- No acceptance criteria for AI performance: The document focuses on proving substantial equivalence to existing predicate devices based on design, materials, and mechanical testing, not on meeting specific performance metrics for an AI algorithm.
- No reported device performance for AI: There is no AI component to this device.
- No sample size for test set or data provenance: These concepts are not applicable to the non-clinical testing described.
- No experts to establish ground truth or adjudication methods: Not applicable to the type of device and testing presented.
- No MRMC study: Not relevant for this physical implant.
- No standalone algorithm performance: The device is an implant, not an algorithm.
- No ground truth type: Not applicable.
- No training set size or ground truth establishment for training set: Not applicable as there is no AI component.
The "Non-clinical Performance Data" section states: "The evaluation of simulated device volumes in the femoral neck and head demonstrates that the subject device does not present a new worst case for use in femoral neck fracture fixation compared to the predicate and reference devices. Hence it supports the proposed expanded 'Indications for Use' for the subject device." This is a biomechanical assessment, not an AI performance study.
The document explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence." This further confirms that the kind of performance study you are asking about, which typically involves clinical data and AI evaluation, was not performed or required for this submission.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.